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CHENGDU, China - Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKEX:6990), a prominent biotechnology player with a market capitalization of $11 billion and strong revenue growth of 25.48% in the last twelve months, announced Wednesday that its partner Windward Bio AG has initiated the Phase 2 POLARIS clinical study to evaluate SKB378/WIN378 for asthma treatment.
The global, randomized, double-blind, placebo-controlled study will assess the dosing, safety, and efficacy of the long-acting monoclonal antibody in asthma patients, with initial data expected by mid-2026.
SKB378/WIN378 is a recombinant fully human monoclonal antibody that targets thymic stromal lymphopoietin (TSLP), a cytokine involved in various immunological conditions including asthma and chronic obstructive pulmonary disease (COPD).
The antibody has been engineered for extended half-life and is administered subcutaneously. A completed Phase 1 trial confirmed its extended dosing potential with a low rate of antidrug antibodies and favorable safety profile.
In January 2025, Kelun-Biotech and Harbour BioMed granted Windward Bio exclusive license rights for SKB378/WIN378 globally, excluding Greater China and several Asian countries. That same month, China’s National Medical Products Administration approved an Investigational New Drug application for the antibody’s use in COPD treatment. The company’s stock has shown remarkable performance, delivering a 148.52% return over the past year and currently trading near its 52-week high of $50.73.
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Additional clinical trials for COPD are planned for 2026, according to the company’s press release statement.
Windward Bio, a clinical-stage biotechnology company focused on immunological conditions, launched earlier this year with a $200 million Series A funding round.
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